Milla d.o.o. – FDA Inspection, Sep 18, 2019

Record Details

This FDA Inspection record concerns Milla d.o.o., with an inspection on September 18, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Milla d.o.o.
Inspection Date: September 18, 2019
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Craig D. Zagata (FDA Associated Person)

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ID · e841b068-1f30-4906-881f-0aa1fb935e03

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 1102457
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued

FDA Citations

21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
21 CFR 211.100(a)Absence of Written Procedures
21 CFR 211.166(a)Lack of written stability program

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FDA Inspection

Milla d.o.o.September 18, 2019